On Thursday, 4/11/24, Dr. Robert Califf, the Deputy Commissioner of the Food and Drug Administration (FDA) was called to testify before Congress regarding many works of the FDA.... or lack of works.... might be a better way to put it...
This Oversight Hearing was a review of the whole Food and Drug Administration. The FDA is a regulatory agency that regulates food, medications / drugs, medical devices, cosmetics, tobacco, and more products in the U.S. and provides guidance and check-points in each of these industries to assure safety!
Read on below to learn more about this Hearing and some astonishing things I noted!
And as a prewarning apology, this will probably be on the longer side of Blog Posts... but the info is too important and a bit too crazy not to share entirely!
Now, before we get too far along here, I do want to say 1 thing; I do not envy Dr. Califf's role as Deputy Commissioner of FDA. It was noted during the closing remarks, how truly monumental the works and efforts he and the FDA are handling on a daily basis are!***
Like, I genuinely would NOT want this job. Nonetheless, Dr. Califf knew what he was signing up for, given his previous experience in working in the FDA. So, the empathy train can only chug along those tracks for so long...
A few key things stuck out to me during this Hearing:
WTF about the infant formula shortage and supply concerns
Limited Inspections are Occurring.. STILL
FDA may need to reassess priorities
Common issues seem to cross the borders of departments in FDA.
Let's Take A Closer Look
While I was somewhat disappointed by the limited focus on the infant formula shortage, there were some key moments throughout that show the dysfunctional state that the FDA is truly in.
The Infant Formula Shortage Crisis
Hands down, the 'best' part and line of questioning when it came to the infant formula shortage during the 4/11/24 Hearing was by Michigan Representative, Mrs. Lisa McClain
The quick focus on this topic said more than enough- Representative McClain came in prepared, and quite frankly, Dr. Califf appears that he did not.. Congresswoman McClain begins by establishing the timeline of when Dr. Califf rejoined the FDA and the infant formula shortage crisis. It is important to note that Dr. Califf took his position as Deputy Commissioner in Feb 2022.
It is also fair to know, Dr. Califf was Deputy Commissioner of Medical Devices and Tobacco Products from February 2015-February 2016, and then Head Deputy Commissioner of the FDA in February 2016-January 2017. It's important to know this because of that empathy train! I KNOW Dr. Califf did not rejoin at an easy moment, and there is always a learning curve when starting a job, whether entirely new or after some time away.... that being said, given that Dr. Califf had previously held the exact position he was placed in makes my empathy dwindle quickly. Why were delays in response so prolonged and poor?
In fact, Dr. Califf has been asked this question a few times over the last two years.. In May 2022, Dr. Califf was questioned by Rep. Morgan Griffith, R-Va., the ranking member on the committee, "why it took the FDA more than three months to address this shortage. Why didn't the FDA "move heaven and earth" to address this", he asked.
FDA's timeliness in interviewing a whistleblower and getting into the Abbott facility for inspections were "too slow," Califf said. "Some decisions in retrospect could have been more optimal." (May 2022)
To many questions from lawmakers on the agency's work flow and timeliness, Califf simply said, "We don't have a great answer."
Seems like that hasn't changed too much in the last 2 years...
Dr. Califf's FDA testimony from May 2022 reveals how long it took agency to respond. Califf's testimony revealed the FDA first had concerns about a baby formula shortage in March 2020, as the coronavirus pandemic choked global supply chains. "The system seemed to be keeping up with demand until fairly recently, although there were spot shortages that we were responding to," Califf said.
The FDA learned on Sept. 20, 2021, of a child that had been diagnosed with a cronobacter infection, which can be fatal in infants. The cronobacter bacteria that causes it has been detected in baby formula, with this particular incident focusing on Abbott Nutrition products. FDA inspectors conducted a routine inspection at the formula plant from 9/20/21-9/24/21, ultimately finding the facility in a "clean and sanitary condition."
Well, thats at least what mainstream media and the FDA / Abbott Nutrition want you to believe...
Reality? FDA Inspection reports back to February 2021 show some major concerns and problems, including standing water, cracks in equipment, They even note some findings such as: a box fan blowing towards the Drying Area that had extensive debris and dust built up, personnel working directly with infant formula and its raw materials were not properly washing hands nor utilize basic food safety protocols such as changing out gloves appropriately, sanitizing areas, etc.
Whistleblower reports come October 20, 2021. The whistleblower was not truly interviewed until late December 2021. On December 6, 2021, FDA initiated inspectional planning for a for-cause inspection at the Sturgis facility with an anticipated inspection date in early January 2022. We notified Abbott Nutrition of the planned inspection on December 30, 2021. Abbott Nutrition responded by notifying FDA of approximately a dozen COVID-19-positive employees in its facility. Although FDA delayed inspection temporarily because of these COVID-19 infections, FDA commenced our inspection on January 31, 2022.
These findings were even worse than September..2021.. The January report directly starts by saying: "You did not establish a system of process controls designed to ensure infant formula safety. It was also noted that the sample batch of formula on 2/1/22-2/2/22 did test positive for Cronobacter. The narrative then became, 'the strains of bacteria do not match.'
A "for cause" inspection was not conducted at the Sturgis, MI plant until Jan. 31, more than four months after the whistleblower reached out to the FDA. By then, three infants had been confirmed to have a Cronobacter infection. Two babies were hospitalized and one had died. The FDA became aware of the fourth infant on February 17, 2022.
If you are curious and want to check out that September 2021 report yourself, here it is!
Want to check out the January 31-March Inspection Report? Click below!
When President Joe Biden was questioned by reporters on May 13,2022 (...seriously? May 13??) about whether his administration should have anticipated the baby formula shortage or reacted in a quicker manner, his answer was pretty astounding.. and right in tune with this entire scenario...
"I don't think anyone anticipated the impact of the shutdown of the Abbott facility. Once we learned of the extent of it, we kicked everything into high gear. And I think we are on our way to be able to completely solve the problem.." (said in May 2022....)
During this conference, reporters had heard directly from CEOs of major formula companies, many of whom spoke of their concerns and earlier warnings, months prior to this conference. When a reporter asked, "didn't the CEOs just say that they knew it would have a very big impact?"
President Biden: "They did, but I didn't."
As he goes on to explain that the formula shortage mainly became a problem once Abbott's Sturgis facility was closed, "So, you're saying that they should have anticipated that it would be shuttered?"
.. Yeah, it kinda seems like the warning signs were pretty clear here..
According to President Biden, he became aware of how intense the situation was in early April 2022.
"If we’d been better mind readers, I guess we could have, but we moved as quickly as the problem became apparent to us," he said. "And we have to move with caution as well as speed, because we got to make sure what we’re getting is, in fact, first-rate product. That’s why the FDA has to go through the process."
"The FDA didn't have to read minds...they just had to read their own data," she said. Rep. Cathy McMorris Rodgers, R-Washington,
In an NPR interview with Tamara Keith, who had been keeping an eye on the situation as it was unfolding, this was acknowledged, showing just how prevalent the situation already was before many addressed the topic,
KEITH: "Yeah. This is not a new crisis. It goes way back to February, when a major Abbott factory in Michigan had to be shut down over safety concerns. The FDA is working with that company, but the factory is still closed."
And it seems that Mr. Califf was not too concerned about the scenario by that point in time. "Our data indicates that in stock rates in retail stores are stabilizing but we continue to work around the clock to further increase availability," Califf said on Twitter. (May 2022)
Another Key Piece they all got wrong- How long will the baby formula shortage last?
"The baby formula shortage will drag on at least another month, according to testimony May 2022. Abbott, the largest producer of formula in the U.S., will start production at the Sturgis plant during the first week of June, according to Abbott Senior Vice President Christopher Calamari. It will take 6 to 8 weeks before products are on the shelves, he said. "We know we let you down, and we're going to do everything we can to re-earn your trust," Calamari said.
Okay, so what about Congresswoman McClain?
Well, she brought so many of these issues and concerns back into the light!! + exposed just how little has actually changed... & Dr. Califf seemed to have even worse answers for these questions than he did before..
As Michigan rep, Lisa McClain began her questioning, she asked some pretty straightforward questions.
"When taking office, were you aware that an infant formula manufacturer that makes over 40% of the infant formula was voluntarily recalling all of the baby formula it made at it's Sturgis plant?"
Dr. Califf: "I was well aware, it happened on the day I was confirmed." *quickly adds in, "but I didn't know before"
In the days and weeks after assuming office, were you aware there was an infant formula shortage across the country?
Dr. Califf: "well in the first days and weeks, there wasn't a shortage,." (inaccurate)
"But as the shortage evolved, I was very much aware."
Congresswoman McClain shares a few additional stats on out of stock rates, followed by:
"I'd like to enter into the record, 2 internal email exchanges, the first dated February 4, 2022, in which FDA officials are discussing the POTENTIAL of a infant formula supply issues and asking for support from the White House and media support in helping to educate the public. shortage. The second, dated February 19, 2022, in which FDA officials are discussing supply issues that were ALREADY happening. Now, despite these discussions within the FDA, media and the President were not aware of the problem. Even though it was headlining locally across the nation for 3 months. So my question, did the FDA not raise concerns, even before the recall?"
Dr. Califf starts talking about a task force?
Congresswoman McClain: "So it was elevated?"
Dr. Califf: "Well, to the task force"
McClain: "Did the FDA raise concerns about a potential shortage before the recall? Yes or No?"
Dr. Califf: "I can't speak to before the recall just about the time of the recall."
McClain: "Okay, let me help you! The FDA did in fact raise concerns with 9 White House Officials and President Biden took no action. I'd like to enter into record, an email between the FDA and White House Staff. This email dated from February 17, 2022, the day of the recall, shows in fact that the White House was in communication with the FDA. I'd like to enter ANOTHER email into the record, dated February 20, 2022, showing the FDA raising concerns. My question, Why did it take President Biden so long to act?"
Dr. Califf: "I can't speak for President Biden about the particular decision. I don't have the specific emails you are referring to, but this evolved over time, so the exact timing of when the DPA should have been brought in is a matter of discussion."
McClain: "A matter of discussion?? That's your answer? Your FDA office is in contact with the 9 White House Staffers and it's a matter of discussion? Either the FDA didn't tell them or the White House didn't act, which is it??:
Dr. Califf: "I think you have the emails, I can't really comment beyond"
McClain: "You know what baffles me? You make about $200K, you're supposed to be in charge, but when the you know what hits the fan, you all run for the hills I'm going to change topics.."
Dr. Califf: "Now hold on a moment"
McClain: "It's my time, sir. When asking about the handling of this is just unbelievable. You dont have an answer, I'd love to have an answer..."
Dr. Califf: "Well, you're overestimating my salary there."
McClain: "it's~$191,000, close enough.
Dr. Califf: "haha, not even that."
McClain: changes topic
In the final closing remarks, Congressman Jamie Raskin commented on the need for all to work together to understand what truly happened in the infant formula shortage and how the blame should not be placed solely on the FDA. Mr. Raskin sent shockwaves to me personally, as he commented that "Democrats never received all the documents promised by Abbott Nutrition"
Check out my recent Instagram Reel on this topic!
Limited Inspections and Funding
This applies to formula producers, food manufacturers, drug manufacturers, tobacco products, and beyond...
FDA is simply not meeting the needs for food inspections and drug inspections...
COVID-19 was primarily blamed for the stark drop off in inspections...
This Hearing took place 4/11/24...
From what I recall, life had returned to fairly normal status by 4/11/22 with regards to COVID-19 and work and public life. Why in the world are we still SO FAR off the goal number of inspections???
I don't think COVID-19 is the reason...
FDA has a 'work from home' policy that seems to have given some leeway here..
Congresswoman Rashida Tlaib asked, "how much of the FDA resources or budget are allocated to food safey?"
Dr. Califf: "I'd refer you to the Reagan Udall Foundation report conducted last year"
Rep Tlaib: "okay, is it like 50%?"
Dr. Califf: "hah no where near 50%, although the F in FDA stands for Food. On the medical side, we've had help with funding due to the user fees"
She then submits, "The FDA's Food Failure" to the record! - This is a fantastic, in-depth article, authored by one of my favorites, Helena Bottemiller Evich! ❤❤
As Representative Tlaib continues in her questioning, she asks a specific question regarding a potential water contamination incident and asks, "Have we fixed this kind of issue?"
Dr. Califf: "you know, when you say, "is it fixed?", well what I would say, the economists rated the U.S. Food Safety as tied for first in the world, but is it completely fixed?"
Congresswoman Tlaib responded perfectly to the poor answers provided, expressing the concern for food safety and the reality that every American is impacted by food and nutrition. This sector needs to have much more of a focus moving forward.
Priorities in the Projects
While major concerns are known for food safety, tobacco and vape safety, cosmetics, high levels of metals in foods, and an entire FDA restructuring (the largest in agency history as Dr. Califf reminded us a few times!), some of the projects of focus do not seem to totally align...
Huge focus on front of package nutrition labels -
Dr. Califf mentioned MANY times, the decline in expected lifespan for US adults, noting a few times the concern of poor nutrition and lack of quick availability of this information....
While I am all for these 'front of package nutrition labels', it struck me to be odd how much emphasis is being put on this initiative as a 'fix' for the declining life span we are seeing..
Reasons this feels more like a distraction than true help:
We are seeing elevated levels of heavy metals in foods, including the recent Cinnamon Applesauce Recall due to lead contamination in which hundreds have had adverse effects. Dr. Califf acknowledged the long-term consequences that can be associated with lead poisoning, including cognitive impairment. Doesn't it seem like THIS would be a better focus?
There have been TONS of medication shortages over the last few years for a variety of reasons. Some of these medications are NECESSARY for those who take them! A perfect example, I once had a patient admitted to the ICU due to fluid overload. This patient had a history of heart disease and needs to take a diuretic each day to help control fluid build up and distribution in their body. At one point, this patient's diuretic was Out Of Stock, leaving this patient without this medication for days. Over the course of these days, the patient's fluid did begin to build up, making it even harder for their heart to pump! They ended up in the ICU to help control this scenario before the patient's heart potentially could give out.. All in less than a week of not having access to the medication they needed...
Through my 10 years of work as an R.D., primarily working with adults with chronic illness, I have never been told that the location of the nutrition label is a primary hindrance in making changes. If a patient wants to make a dietary change, they will. Whether the label is on the front or not. In addition, most of the time, once someone finds a product or brand that fits their needs, Nutrition Label Reading does not become quite as extensive..
Does the FDA even have authority to make some of the changes they have proposed??
The FDA should be a neutral party, providing information based solely on evidence. Some of the proposed label changes include: Providing an indicator for a "Healthy" food (What is "Healthy"?) ; a stoplight approach of Red, Yellow, and Green Foods - Again, what qualifies under "red aka bad" and "green aka good" and why is the FDA deciding this?
One of my favorite questions of the day came from Kansas representative, Mr. Jake LaTurner: "Can you explain to the committee what authority you feel the FDA has in pursuing nutrition labeling policy, while heavy metals exist in our food supply, elicit Chinese tobacco products remain accessible, and 263 drugs in shortage?"
Dr. Califf spoke a bit too much (in my opinion) on his personal thoughts of the benefits of front of package nutrition label.. stating "he's a simple boy from South Carolina" and noting that a quick reference would be of benefit. His direct answer to the question above, "we have a law we are adhering to, and I would remind you, we have a shortened life expectancy in this country, particularly in rural areas, that's largely driven by diet and poor nutrition. It seems to me, I'm just from South Carolina, it seems to me, that putting the information on the front of the package is probably more likely to get the useful information so people can make wise choices. That doesn't seem to me like something should be that hard to get to, If you put it on the back, if you're like me when you go to the store, you're unlikely to look at it."
(Asked, "ok, can you tell me where you derived that authority specifically?") ; "I'd be glad get with your staff and go through the details of that, but we believe we do have the authority"
(Do you feel its a best use of taxpayers dollars, to shape American eating patterns, in lieu of addressing some of these other critical issues? I listed a few issues that seem like a pretty big deal..") ; talks about shortened life expectancy primarily being driven by diet again, talks about diet and chronic disease, "I tell my Cardiology colleagues, we got no problem with business in the future in Cardiology"
It was clear that Mr. LaTurner felt similar in his reactions to Dr. Califf's responses above, stating, "okay, I only have a limited amount of time. I pointed to front of pack labeling as an example, but it appears the agency has a number of outstanding rule makings and goals that are not related to food safety. The definition of "Healthy", a symbol for "healthy", dietary guidelines for Americans, dietary guidance statements, the list goes on.. Can you please tell the committee how all these pieces fit together? My concern is, that not only are you pursuing actions that you do not have the authority for, but you are also painting a terribly confusing landscape of rules and advice about what to eat."
Dr. Califf's response?
"Well, I'd be happy to work with your staff in more detail, but what we now know about diet, it is a pattern of eating over time that's important in how long people live and whether they are burdened by chronic diseases. It's not one specific thing, it's multiple constituents of the diet when eaten regularly in a pattern, create the types of health problems that are really ravaging our country right now, particularly in rural areas. we're seeing alarming premature death rates that are going in the wrong direction for the first time in 50 years"
Kansas Representative, Mr. LaTurner, "You said that earlier. My question is specifically, all of these different initiatives, how they work together, and I look forward to getting an answer on that, to my actual question."
Literally, just... wtf??
Our head of FDA... "but what we now know about diet, it is a pattern of eating over time"
Dr. Califf's written testimony on this topic:
"Front and center is FDA’s development of a front-of-package labeling system to quickly communicate and provide additional context to certain nutrition information. This has the potential to be as iconic as the Nutrition Facts label. Front-of-package labeling could help consumers, especially those who may be less familiar with nutritional information, identify foods that can help them build a healthy eating pattern."
And while I am not opposed to front of package labeling or some of the other initiates put forth, this entire series of questions was a huge revelation for me!
In my 10 years as a Registered Dietitian, I have also seen some of the most bizarre nutrition guidelines and recommendations come from Physicians, often with limited nutrition education/background in the grand scheme. This encounter gives me that feeling..
Some other really astonishing Key Takeaways & Topics / issues addressed during the FDA Congressional Oversight Hearing (April 2024):
Limited Ownership across Departments
Essentially 0 progress noted to the Closer To Zero movement...
Medication labeling with allergens
Medication Shortages, Generic Medications, and the Orange Book
Illegal vapes, in many ways worsened by slow action of approval of safer options by FDA, tobacco policies
Misinformation
Reproduction and Medications
Many vague answers across the board.. and I think approx. 7+ Congress members called out Dr. Califf regarding his lack of email correspondences and responses
This Hearing said... A LOT.... I could probably write MUCH more, but I'll save you all for now..
I have been so excited to see where the FDA restructure will lead us, and I'm PRAYING it leads us somewhere better than where we currently are...!
This has been going on for far too long...
Want to check out the Hearing for yourself and learn more about these topics + the other endeavors at the FDA?! Click Here:
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